Open-Label Study of ARD-0403 in Testosterone Deficient Men | NCT00562731

Studies
Open-Label Study of ARD-0403 in Testosterone Deficient Men

NCT00562731

Sponsor

Ardana Bioscience Ltd

Status

Terminated

Last Update Posted

Apr 1, 2008Estimated

Enrollment

150Estimated

Phase

Phase 3

Conditions

Hypogonadism

Interventions

ARD-0403

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Company strategic decision

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Not provided

Completion Date

Jun 2008Estimated

First Submitted Date

Nov 21, 2007

First Submission Date that Met QC Criteria

Nov 21, 2007

First Posted Date

Nov 22, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2008

Last Update Posted Date

Apr 1, 2008Estimated

Description Module

Brief Summary

Male hypogonadism, a disorder associated with testosterone deficiency, is frequently seen in clinical practice and has significant effects on patient well-being. The purpose of this study is to investigate the efficacy and safety of ARD-0403 as a testosterone replacement therapy in testosterone deficient men.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Name	Type	Description	Arm Group Labels	Other Names
ARD-0403	Drug	Daily transdermal ARD-0403

Measure	Description	Time Frame
Efficacy		Study Duration

Measure	Description	Time Frame
Safety and Tolerability		Study Duration

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Testosterone deficiency
Completed study ARD-0403-004

Exclusion Criteria:

Previous treatment with testosterone replacement therapy within 4 weeks
Moderate-severe benign prostatic hypertrophy or prostatic cancer
Haematocrit >50%

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
R Swerdloff	University of California, Los Angeles	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Affiliated Research Center, Inc		Huntsville	Alabama	35801	United States
Stanford University

Condition Browse Module

MeSH Terms

ID	Term
D007006	Hypogonadism

Ancestor Terms

ID	Term
D006058	Gonadal Disorders
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided